The Clinical Trials Management Unit is responsible for overseeing the operational activities of the commercial clinical studies at the Vall d'Hebron Campus. The primary objective of this Unit is to support clinicians and Principal Investigators of Vall d'Hebron Campus in conducting their clinical studies in accordance with each protocol, while adhering to GCP and current regulations.
Over the past year, the number and complexity of clinical trials at Vall d'Hebron University Hospital have significantly increased, contributing to improve life expectancy for our patients. This growth demands a well-organized, methodical, and people-oriented individual who is eager to develop a career in this field.
Position AvailableThe Clinical Trials Management Unit is seeking to fill one position for a Senior Study Coordinator. This call will focus on clinical trials within the Chronicity and Neurosciences area of knowledge.
Education and QualificationsRequired: Master's degree in Clinical TrialsSpecialist in administrative management of Clinical Trials (CTA)Bachelor's Degree in Health Sciences preferable but open to other related disciplinesActic level 3 (computer and office program skills)Fluency in Catalan, Spanish, English (business level)Desired: Certification in Project Management and Data Analysis Training in Good Clinical Practice (GCP) and clinical trials methodology Experience and KnowledgeRequired: More than 3 years of experience as Study CoordinatorKnowledge of database programsAbility to work independently as well as in a team environmentGood communication skills and fluency in written and spoken EnglishDesired: Experience with SAP management programOrganized and methodical person with high motivation and initiativeQuick response to time requested by the team and sponsor Main Responsibilities and DutiesClinical Trial Oversight and Coordination: Ensure all clinical trial activities adhere to the study protocol, Good Clinical Practice (GCPs), and regulatory requirements; oversee patient recruitment strategies and retention plans to meet enrolment goals; monitor compliance with the study timeline, deliverables, and ethical guidelines; address and resolve any operational challenges that arise during the trial.Team Leadership and Mentorship: Mentor junior study coordinators, data entry staff, and other team members involved in the clinical trials; provide training on protocols, GCP, and institutional policies.Communication and Liaison: Work closely with principal investigators (PIs) to ensure trials are conducted smoothly and effectively; ensure consistent communication between sponsors, investigators, and the research team.Regulatory and Documentation Management: Ensure compliance with all applicable laws, regulations, and institutional policies; oversee the maintenance of regulatory documents, site files, and patient records; prepare for and participate in audits or inspections by sponsors or regulatory authorities.Study Planning and Logistics: Coordinate and schedule study visits, ensuring all pre-visit requirements are met; supervise the accurate collection, handling, and recording of study data and biological samples.Quality Assurance: Verify all study data is accurate, complete, and entered into relevant systems promptly; ensure all documentation and records adhere to ALCOA+ principles; coordinate and support with on-site and remote monitoring visits and implement corrective actions as needed.Budget and Financial Management: Collaborate with the finance team to track trial budgets and expenses; monitor invoicing and payments to ensure proper reimbursement for study activities.Innovation and Process Improvement: Identify areas for process improvement and implement changes to enhance efficiency and compliance; leverage clinical trial management systems (CTMS) and other tools to streamline operations and reporting. Labour ConditionsFull-time position: 40h/weekStarting date: ImmediateGross annual salary: Salary ranges are consistent with our Collective Agreement pay scale.Contract: Linked to project (2 years approximately). There are 2 positions for this vacancy. What Can We Offer?Incorporation to Vall d'Hebron Research Institute (VHIR), a public sector institution that promotes and develops biomedical research, innovation, and teaching at Vall d'Hebron University Hospital (HUVH).A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.Continuous learning and a wide range of responsibilities within a stimulating work environment.Individual training opportunities.Flexible working hours.23 days of holidays + 9 personal days.Flexible Remuneration Program (including dining checks, health insurance, transportation, and more).Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports, among many others.Healthy Offering: choose from a variety of wellbeing-focused activities to be the healthiest you. Deadline to apply: 20-12-2024
VHIR embraces Equality and Diversity. As reflected in our values, we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, functional diversity, or ethnicity.
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